Fecal incontinence treatment device and method

ABSTRACT

Various embodiments of an implant system for treating fecal incontinence are provided. The devices and systems can include a mesh or like device that can include a variable porosity to control the degree of expansion of the anal canal. The mesh can be constructed at least in part of patterned strut members allowing for various geometric configurations, with varying load and tension properties for the designated portions of the device according to the needs for a particular patient application.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of, and claims priority to, U.S.patent application Ser. No. 13/599,990, filed on Aug. 30, 2012, entitled“FECAL INCONTINENCE TREATMENT DEVICE AND METHOD”, which, in turn, claimspriority to U.S. Patent Application No. 61/529,132, filed on Aug. 30,2011, the disclosures of which are incorporated by reference herein intheir entirety.

FIELD OF THE INVENTION

The present invention relates generally to surgical methods andapparatus and, more specifically, to surgically implantable fecalincontinence devices and methods for forming and using the same.

BACKGROUND OF THE INVENTION

Pelvic health for men and women is a medical area of increasingimportance, at least in part due to an aging population. Examples ofcommon pelvic ailments include incontinence (e.g., fecal and urinary),pelvic tissue prolapse (e.g., female vaginal prolapse), and conditionsof the pelvic floor.

Fecal or anal incontinence is a condition characterized by involuntarydefecation or passage of feces through the anal canal due to injury toor weakness of one or more of the internal anal sphincter, the externalanal sphincter, and the levator ani. Fecal incontinence can be theresult of an atrophied or damaged anal sphincter muscle or a sphinctermuscle that incorrectly responds to neural signals. The problem is torestore the radial closing force of the disrupted sphincter muscle inorder to restore fecal continence.

More recently, an artificial anal sphincter has been used to bypassthese muscles, though this surgery involves fairly extensive dissectionand requires the patient to depress a subcutaneous valve whichtemporarily deflates the sphincter cuff and allows voluntary defecation.This procedure is performed in very few centers in the U.S., and even inexperienced hands, complications occur frequently. In addition, sacralnerve stimulation has been used with some success to treat fecalincontinence, though the mechanism of success in these patients remainsunclear, and may not be appropriate in women with obvious anatomicabnormalities, such as anal sphincter or levator muscle disruptions.

Further, many women report other symptoms of bowel dysfunction, such asconstipation and incomplete bowel emptying. For some women, thesesymptoms are due to either an anterior rectocele (a hernia of the rectuminto the vaginal canal), or due to a defect in the levator ani muscles,which results in descent of the levator plate and/or perineum withabdominal straining. In addition, patients may be noted to have a defectin the posterior aspect of the rectum, or a posterior rectocele. Thereare very few treatment options for this condition, though retrorectallevatorplasty has been used in the past. In this procedure, an incisionis made between the anus and the coccyx and the levator muscles areexposed bilaterally. Sutures are then placed in the levator muscles toplicate them together in the midline.

There is a desire to obtain a minimally invasive yet highly effectiveimplantable member or mesh that can be used to treat incontinence,and/or pelvic organ prolapse and other conditions.

SUMMARY OF THE INVENTION

The present invention describes devices, systems and methods fortreating incontinence, including fecal incontinence. The devices andsystems can include a cylindrically shaped member, such as mesh, thatcan include a variable porosity to control the degree of expansion ofthe anal canal. Pores or openings in the member can be shaped andpatterned to allow for resistance to expansion (hold sphincter closed),yet also allow expansion or elongation during the passage of materialthrough the sphincter. The mesh can be constructed at least in part ofpatterned strut members allowing for multiple geometric configurations,with varying load and tension properties for the designated portions ofthe device. The mesh device can be placed around or within the analsphincter muscle. At least one incision may be used to place the implantand then ends of the implant can be joined to form a cylindrical shapeto surround and restrict the sphincter muscle. As a result, anadaptable, e.g., limited expansion and restriction, implant device isincluded to provide variable expansion control to promote continencewithout the use of inflatable devices or related complicated mechanismsand systems.

Various embodiments of the implant device can include a plurality ofsegments. The segments can be spaced and connected by one or moreextension members. The segments and/or the extension members can beconstructed of mesh filament members, unitary strut members, or likeconstructs.

In other embodiments, a variable spring-sleeve implant can be included.A variable wound spring, in a sleeve, can be inserted into the analcanal in order to restore continence. Alternatively, the spring-sleevemay be implanted around the anal sphincter muscle. Still further, thespring can be implanted without a sleeve portion to promote continence.The sleeve isolates the spring from the surrounding tissues, allowing itto radially expand without interference from tissue in-growth. In its“resting state” the spring would have a smaller diameter at the samelevel of the sphincter. As the patient bears down to pass materialthrough the sphincter, the diameter of the spring expands to allowmaterial passage. Such a solution will allow passive closure of the analsphincter to restore continence to the patient, and active expansionduring the passage of material through the anal canal. For insertioninto the anal canal, the spring-sleeve may be wound down and insertedinto a catheter. For implantation, a similar delivery catheter would beused. The outer surface would allow for suture placement and tissuein-growth if desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows various relevant anatomical structures of the rectum, anusand internal anal sphincter muscles.

FIG. 2 is a schematic view of an implant device wrapped around a portionof the anal sphincter to promote fecal continence, in accordance withembodiments of the present invention.

FIGS. 3-7 are schematic views of an implant device being connected atopposing ends to provide a generally cylindrical configuration topromote continence, in accordance with embodiments of the presentinvention.

FIGS. 8-9 are schematic views of elongate implant devices havingdistinct patterned cell portion to promote continence, in accordancewith embodiments of the present invention.

FIGS. 9a-9b are partial schematic views of exemplary patterned strutsand cell portions for use with an implant device, in accordance withembodiments of the present invention.

FIG. 10 is a schematic view of a generally cylindrical implant devicehaving distinct patterned cell portions to promote continence, inaccordance with embodiments of the present invention.

FIGS. 11-14 are schematic views of various implant devices havingsegments and extension members to promote continence, in accordance withembodiments of the present invention.

FIG. 15 is a schematic view of a spring and sheath implant device fordeployment within the anal canal to promote continence, in accordancewith embodiments of the present invention.

FIG. 16 is a partial sectional schematic view showing a spring attachedwithin a wall of a sheath for an implant device in accordance withembodiments of the present invention.

FIG. 17 is a schematic view of a collapsed sheath for an implant devicein accordance with embodiments of the present invention.

FIG. 18 is a schematic top view of a collapsed sheath for an implantdevice in accordance with embodiments of the present invention.

FIG. 19 is a top schematic view of a bi-leaflet like valve implantdevice for use to promote continence in accordance with embodiments ofthe present invention.

FIG. 20 is a side schematic view of a bi-leaflet like valve implantdevice for use to promote continence in accordance with embodiments ofthe present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring generally to FIGS. 1-20, various embodiments of implantabledevices or systems 10 and methods for treating fecal incontinence areshown.

The devices 10 can be joined to form a cylindrically shaped member ormesh (e.g., cuff) structure that can include a variable porosityattributes to control the degree of expansion of the anal canal. Poresor openings can be shaped and patterned to allow for resistance toexpansion (e.g., hold sphincter closed), yet also allow some expansionor elongation during the passage of material through the sphincter,thereby better mimicking the natural anatomical structure and behavior.

FIG. 1 one shows typical anatomical structures of the patient, includingthe rectum R, internal anal sphincter muscles or tissue S, and the anusA.

In various embodiments, as shown in FIGS. 2-14, the implant device 10 isa generally elongate device in its initial state. The elongate device 10can include a first end portion 12 a and a second end portion 12 b, aswell as a central support or restriction portion 13. Before or afterdeployment to the target site for restriction, such as the sphincter,the device 10 wraps around the sphincter muscle and the end portions 12a, 12 b are engaged or interlocked to retain the device 10 in place toprovide the desired restriction to promote continence.

As shown in FIGS. 3-7, the device 10 can be generally flat or elongatein its initial form or state, and wrapped around a portion of theinternal anal sphincter muscle, and connected via the mechanisms 18, tocreate a generally cylindrical cuff configuration around the muscle, ora proximate anatomical area, to promote continence.

As illustrated in FIGS. 8-10, the device 10 can be constructed at leastin part of patterned strut members 14 allowing for multiple geometric ormesh configurations, with varying load, compression, elasticity, tensionand like properties for the designated portions of the device 10. Assuch, at least a portion of the implant device 10 can have a generallyconsistent homogenous or unitary patterned cell construct 16. The entiredevice 10 can be constructed of the unitary patterned cells or just adesignated section, or sections, can include the patterned strutconfiguration attached to or integrated with interwoven mesh filamentportions.

The device 10 can be placed around or within the anal sphincter muscle S(e.g., FIG. 2). In certain embodiments, one or more incisions can bemade to provide access to the pelvic space, e.g., between the anus andthe vagina or scrotum, and the end portions of the implant 10 can bejoined together around the anal sphincter to form a cylindricalrestriction structure around the sphincter to promote continence. Asshown in FIG. 10, the cylindrical implant 10 can be generally taperedalong a portion thereof to control continence.

For those embodiments employing a mesh construct having one or moreunitary patterned cells 16 defined from struts 14 (e.g., undulatingstruts), the implant devices 10 can be formed by way of a molding, diecasting, laser etching, laser cutting, extruding, and the like.Exemplary patterns and strut 14 configurations for the patterned cellportions 16 are depicted in FIGS. 9a-9b . Such a pattern cut or formedimplant can be constructed of a polymer material to provide a latticesupport structure of repeated cells. The various implant devices, devicepatterns and properties, techniques, systems and methods disclosed inU.S. Patent Application Publication Nos. 2011/014417 and 2011/0124956can be implemented with the embodiments of the present invention and asa result, the above-referenced publications are incorporated herein byreference in their entireties. In other embodiments, all or a part ofthe device 10 can also be constructed of interwoven or knitted membersto form a mesh implant.

The patterned cell portions 16 can be formed into sinusoid or otherwaveform strut members 14 (e.g., FIGS. 9a-9b ) to promote controlledelongation or expansion along single or multiple axes. As such,controlled and designated stress, tension and compression distributionis better controlled across specific or localized areas of the device10. Consequently, the muscle is restricted to prevent fecal incontinencewhile still allowing for limited expansion or elongation during thepassage of material through the sphincter S and out the anus A. Further,any of the devices 10 can be formed such that regions or portions caninclude the connection mechanisms or devices 18 to facilitateattachment.

For those embodiments that have at least a portion of the implant 10defined by patterned cells, uniquely shaped or cut strut members 14 areconfigured to define cell voids 15, to optimize or increase tissuein-growth, to promote load bearing along select portions of the implant,to compensate for stiffness, elongation, compression, and tensilestrength. The material and cell construct 16 of the implant device 10,or a portion thereof, can be configured to promote flexibility whilestill providing optimal strength and restriction to promote continence.Further, the stable and consistent geometrical and dimensionalattributes of the implant provide a flexible device that can be easilypositioned and deployed while also avoiding undesirable implant warpingor bunching.

In addition to molding and laser cutting the struts 14 and otherfeatures of the implant device 10, punching, 3-D printing and othermethods and techniques can be employed in making the implant. Further,the struts 14 or other portions of the implant device 14 can be coatedto provide additional control over expansion, compression, and toprotect from or promote tissue in-growth.

The mechanisms or devices 18 of various embodiments can include hooks,tabs, joints, locking members, button-like features, snaps, interlockingextensions, sutures and like connection structures or members, toengage, connect or join the first and second end portions 12 a, 12 b ofthe device 10. As shown in FIGS. 3-5, for instance, the first endportion 12 a of the device 10 can include extending hooks orarrow-shaped members 18 a, with the second end portion 12 b includingslotted members 18 b, or features with one or more apertures 19, adaptedto receive and retain the members 18 a. FIGS. 11-12 show an embodimenthaving a button-like member 18 a provided with the first end portion 12a and adapted to connect with a receiving aperture 12 b provided withthe second end portion 12 b.

Various embodiments of the implant device 10 can include a plurality ofsegments 20, as shown in FIGS. 11-14. The segments 20 can be spaced andconnected by one or more extension members 22. The segments 20 canassume the construct of the various filament mesh structures, unitarypatterned cells, generally elastic elements, or other like designs orconfigurations disclosed herein. Further, the extension members 22 caninclude sutures, mesh extensions, elastic members, unitary patternedcells, or a myriad of other elements or members adapted to span between,and in certain embodiments provide variable expansion for the segments20. In certain embodiments, a single extension member 22 can be employedsuch that the segments 20 are positioned are provided along a length ofthe member 22. A kit or other system can be provided with a predefinednumber of segments depending on the specific anatomical dimensions andrestriction requirements of the implant device 10 around the sphincterto promote continence. Moreover, certain embodiments can includesegments 20 selectively added or removed from the length of the implantdevice 10, or a length of an extension member 22, according to theparticular restriction, anatomical or dimensional needs of theprocedure. In particular embodiments, the segments 20 can be constructedof a non-porous and compatible material, such as polymer material.Further, the segments 20 can include channels or like features to allowfor sliding or movement of the segments 20 along a length of anextension member 22. The extension members 22 can be generally elasticin certain embodiments to facilitate deployment and adjustment, whilestill retaining a desirable restriction on the sphincter to promotecontinence upon implantation.

Embodiments of, or portions of, the implant 10 can be constructed of amaterial (e.g., polymer) having surface features or textured regionsadapted to facilitate tissue engagement and/or tissue in-growth.Further, portions or all of the implant 10 can include coatings or otherfeatures to promote tissue in-growth, engagement, or treatment. Forthose embodiments adapted to promote treatment, various agents, drugs,biologics, or treatment or therapeutic substances can be included tofacilitate healing, tissue strengthening or improvement.

In certain other embodiments, as shown in FIGS. 15-20, a variablespring-sleeve implant device 30 can be utilized in the treatment offecal incontinence. A variable wound spring 32, in a sleeve 34, can beinserted into, and/or engaged within (e.g., force fit, sutured oranchored), the anal canal in order to restore continence. The device 30includes openings at each end and a potential passageway therethrough.Alternatively, the spring-sleeve may be implanted around the analsphincter muscle.

The sleeve 34 isolates the spring 32 from the surrounding tissues,allowing it to radially expand without interference from tissuein-growth. In other embodiments, the device 30 can simply include thespring 32, without a sheath 34. In its “resting state” the spring 32 canhave a smaller diameter at the same dimension or level as the sphincterS. As the patient bears down to pass material through the sphincter, thediameter of the spring 32 expands to allow material passage through theinterior of the device 30 and ultimately the canal. Such a solution willallow passive closure of the anal sphincter S to restore continence tothe patient, yet active expansion during the passage of material throughthe anal canal (via the device 30). For insertion into the anal canal,the implant 30 may be wound down or collapsed (e.g., FIG. 17) andinserted into a catheter or like delivery tool. For implantation, asimilar delivery catheter can be used. The outer surface of the device30 or spring 32 can allow for suture placement and tissue ingrowth ifdesired—e.g., including textured surfaces, coatings, mesh portions, andthe like. As shown in FIG. 16, certain embodiments of the device 30 caninclude portions of the spring 32 extending into the wall portion of thesheath 34 to better provide the desired interconnectivity with thespring 32 and sheath 34 for increased operation and control. In use forvarious embodiments, a single perianal or full radius incision of theanal canal can be performed, followed by blunt dissection. The sleeve 34can then be sutured in placed within the canal.

As shown in FIGS. 19-20, a valve-like implant 40 can serve as, or bemodified to provide a desirable valve configuration when inserted intothe anal canal. Accordingly, the implant 30 can be configured to actlike a bi-leaflet valve device that folds or closes (e.g., FIG. 20showing closing motion) to prevent material flow through the lumen untilthe patient sufficiently bears down.

The various implants 10 or systems, features and methods detailed hereinare envisioned for use with many known implant and repair systems (e.g.,for male and female), features and methods, including those disclosed inU.S. Pat. Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525,7,025,063, 6,691,711, 6,648,921, and 6,612,977, International PatentPublication Nos. WO 2008/057261 and WO 2007/097994, and U.S. PatentPublication Nos. 2012/0215060; 2011/0144417, 2008/0242918, 2008/0021264,2002/151762 and 2002/147382. Accordingly, the above-identifieddisclosures are fully incorporated herein by reference in theirentirety.

Embodiments of the present invention can be constructed of knowncompatible materials, including polymers and metals (Nitinol, titanium,stainless steel, etc.).

The implant systems 10, their various components, structures, features,materials and methods may have a number of suitable configurations asshown and described in the previously-incorporated references. Variousmethods and tools for introducing, deploying, anchoring and manipulatingimplants to treat incontinence as disclosed in thepreviously-incorporated references are envisioned for use with thepresent invention as well.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the teachings herein. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced other than as specifically described herein.

What is claimed is:
 1. An implant device for treating fecal incontinencein a patient, comprising: a restriction member having a first endportion, a second end portion, and an intermediate restriction portionadapted to wrap around a portion of an anal sphincter of the patient,the intermediate restriction portion including a first portion and asecond portion, the first portion including interwoven filaments andextending from the first end portion to the second end portion, thesecond portion including a plurality of non-woven struts and extendingfrom the first end portion to the second end portion, the plurality ofnon-woven struts being interwoven with the interwoven filaments, theplurality of non-woven struts including voids configured to increasetissue in-growth, the voids being disposed between the plurality ofnon-woven struts; at least two first connector elements provided at thefirst end portion; and at least two second connector elements providedat the second end portion and adapted to connect with the at least twofirst connector elements to retain the restriction member around theanal sphincter of the patient to promote continence.
 2. The device ofclaim 1, wherein the restriction member is generally elongate.
 3. Thedevice of claim 1, wherein the plurality of non-woven struts includesinusoid struts.
 4. The device of claim 1, wherein the at least twofirst connector elements include a first hook member and a second hookmember.
 5. The device of claim 1, wherein the at least two secondconnector elements include a first member having a first receivingaperture, and a second member having a second receiving aperture.
 6. Thedevice of claim 1, wherein the second portion having the plurality ofnon-woven struts extends along a length of the restriction member topermit limited expansion of the restriction member wrapped around theanal sphincter.
 7. The device of claim 1, wherein the at least two firstconnector elements are selected from the group consisting of: a tab, aclip, a snap device, a hook, and a button member.
 8. The device of claim1, wherein the plurality of non-woven struts is coated with a materialto provide additional control over expansion and compression and promotetissue in-growth.
 9. The device of claim 1, wherein the restrictionmember includes a first side and a second side opposite the first side,at least one of the first side and the second side is tapered.
 10. Animplant device for treating fecal incontinence in a patient, comprising:a restriction mesh member having a first end portion, a second endportion, and an intermediate restriction portion adapted to wrap arounda portion of an anal sphincter of the patient, the intermediaterestriction portion including a first portion and a second portion, thefirst portion including interwoven filaments and extending from thefirst end portion to the second end portion, the second portionincluding a plurality of non-woven struts and extending from the firstend portion to the second end portion, the plurality of non-woven strutsincluding voids configured to increase tissue in-growth, the voids beingdisposed between the plurality of non-woven struts, the plurality ofnon-woven struts include non-linear struts disposed along the first endportion to the second end portion; at least two hook members provided atthe first end portion; and at least two receiving members provided atthe second end portion and adapted to connect with the at least two hookmembers to retain the restriction mesh member around the anal sphincterof the patient to promote continence.
 11. The device of claim 10,wherein the restriction mesh member is generally elongate.
 12. Thedevice of claim 10, wherein the intermediate restriction portionincludes a third portion, the third portion including interwovenfilaments, the second portion being disposed between the first portionand the third portion.
 13. The device of claim 12, wherein the secondportion has an area that covers substantially a third of an entire areaof the restriction mesh member.
 14. The device of claim 10, wherein thefirst portion extends across an entire length of the intermediaterestriction portion, and the second portion extends across the entirelength of the intermediate restriction portion.
 15. The device of claim10, wherein the plurality of non-woven struts include a polymermaterial, and the interwoven filaments define a mesh material, the meshmaterial being different than the polymer material.
 16. An implantdevice for treating fecal incontinence in a patient, comprising: agenerally cylindrical implant having a first end portion, a second endportion, and an intermediate restriction portion, the generallycylindrical implant being adapted to wrap around a portion of an analsphincter of the patient, a portion of the generally cylindrical implantincluding a mesh material constructed of interwoven filaments; and atleast one unitary patterned cell portion defined by a plurality ofnon-woven strut members constructed of a polymer material, the pluralityof non-woven strut members being interwoven with the interwovenfilaments of the mesh material and extend from the first end portion tothe second end portion, the plurality of non-woven strut membersdefining voids, the voids being disposed between the plurality ofnon-woven strut members, the at least one unitary patterned cell portionbeing provided around the generally cylindrical implant to facilitateexpansion and promote continence.
 17. The device of claim 16, whereinthe plurality of non-woven strut members include sinusoidal struts. 18.The device of claim 16, wherein the at least one unitary patterned cellportion includes a first unitary patterned cell portion and a secondunitary patterned cell portion, the interwoven filaments being disposedbetween the first unitary patterned cell portion and the second unitarypatterned cell portion.
 19. The device of claim 16, wherein theplurality of non-woven strut members are formed via laser cutting.